PSA testing and prostate cancer management remain controversial. In recognition of the fact that many prostate cancer treatments are harmful and that many low-risk prostate cancers can be outlived without intervention, a less hurried active surveillance program was developed. Although heavily promoted, is this monitoring program (6 monthly doctor visits for a PSA, prostate exam, and other possible practices – including MRIs and possible biopsies) safe and beneficial or, is it merely a cutdown version of unsafe and scientifically unproven prostate cancer management drills?
1. The prostate exam
The prostate exam or digital rectal exam (DRE) is dependent on the interpretive skills of the doctor and is no more reliable than a coin-toss. Additionally, the sensitivity for detecting prostate cancer is low, and even for those where a “nodule” was felt there’s no scientific evidence that the finding led to life extension. Little wonder, a strong argument exists for eliminating the DRE from physical examinations.
2. The PSA
The PSA (prostate-specific antigen) test is highly unreliable with a false-positive rate of 78 percent. It is neither specific to the prostate nor specific to prostate cancer. Along with fake levels of normal, a raised PSA does not mean prostate cancer, and lowering the PSA does not confer less risk. The PSA can’t distinguish between aggressive and non-aggressive cancers and it can be artificially raised or lowered in numerous situations without cancer being present or advancing. As well, since some aggressive cancers produce little or no PSA they may be missed. Not surprisingly, a 2009 study by urologists showed that PSA testing failed to save significant numbers of lives.
3. The 12-core prostate needle biopsy
The 12-core ultrasound-guided prostate needle biopsy is a grossly unscientific test that potentially exposes patients to serious complications of sepsis and bleeding while sampling blindly and randomly about 0.1 percent of the prostate. With such a large sampling error, missing a cancer is embarrassingly common. And, although one study showed a false negative rate of 30 percent the actual error rate is much greater as over half the “cancers” included were Gleason 5 and 6 pseudo-cancers.
4. Imaging for prostate cancer
Imaging for the detection and staging of prostate cancer using ultrasounds, CT, and bone scans is recognized as being relatively insensitive. For staging, they lack accuracy at detecting small volume spread. Underlining this concern is the fact that prostate cancer cells have been found in the bone marrow of patients with so-called localized disease. The best screening tool for prostate cancer detection appears to be the non-contrast MRI (by an expert) and then a real-time MRI-guided targeted biopsy of areas judged as Pirads 4 or 5 for diagnosis. Staging using the whole-body MRI to detect boney spread and the PMSA PET-CT scan to detect lymph node spread are now considered standard practice.
5. The Gleason 3+3=6 “cancer”
The grade 3 in the Gleason 3+3=6 “cancer” is a classification of cellular growth judged to be consistent with a low-grade prostate cancer under low power microscopy. However, the Gleason grade 3 lacks the hallmarks of a cancer on both clinical and molecular biology grounds. Especially, since the genetic pathways enabling invasion and cancer spread are inactive. And, because biological mechanisms eclipse microscopic appearances, both the Gleason and cancer labels need to be dropped and the grade 3 retagged as a benign disease.
6. The unreliable Gleason grading system
Because of the complexity of the Gleason grading classification system, errors of interpretation and disagreements amongst pathologists are common. Underscoring a profound lack of reproducibility with this very subjective prostate cancer diagnostic system Swedish pathologists disagreed about Gleason grades a staggering 50 percent of the time. Since grade misclassifications are common, second opinions are strongly recommended.
7. The unproven radical prostatectomy “treatment”
Radical prostatectomy has been a fraudulent cornerstone of prostate cancer management since Johns Hopkins surgeon H.H. Young’s claim of early diagnosis, cure, and that “The four cases in which the radical operation was done demonstrated its simplicity, effectiveness and the remarkably satisfactory functional results furnished.” Unbelievably, there was no evidence for early diagnosis or cure, two patients died and the other two were left with lifelong urinary incontinence. Yet, this risky treatment philosophy became standard practice and continues so despite a study concluding that surgery failed to save significant numbers of lives. More disturbingly, when robotics arrived the device received an FDA approval although it delivered no clear surgical benefits. Worse still, the FDA’s fallacious 510(K) process was manipulated to obtain approval for use of the tool in robotic prostatectomy without any evidence for safety or benefits.
8. The false urgency for prostate cancer treatment
The mislabeling of the grade 3 as a cancer has pushed men towards unneeded treatment and falsely increased the incidence of prostate cancer.
Not all prostate cancers are equal – only some 10 to 15 percent of cases are aggressive and potentially lethal and responsible for the deaths of about 30,000 U.S. men annually.
Most men diagnosed with prostate cancer do not die from it. More than 3.1 million men in the United States who have been diagnosed with prostate cancer at some point are still alive today. Surprisingly, the $32.7 billion market for treatments doesn’t appear to drive increased survival.
Many prostate cancers have a cell doubling time of some 475 +/- 56 days so it takes about 40 years for the cell to multiply and grow to a diameter of one centimeter.
The 15-year survival for all prostate cancers is estimated to be about 96 percent regardless of the type of treatment while no treatment has a similar 10-year survival to those who did have treatment.
Bogus cancers, false positives, and errors of interpretation.
The evidence delivered in this review underscores clearly that not only is the Gleason grade 3 a bogus cancer but that there’s an intolerable degree of false positives with PSA testing, an intolerable degree of errors of interpretation in both pathology and imaging, and, that both PSA testing and surgery fail to save significant numbers of lives. According to lore, the definition of insanity is doing the same thing over and over again and expecting a different result. John Ioannidis MD identified a possible cause for this mischief in healthcare when he concluded that most published research findings are false. In light of the many falsehoods surrounding prostate cancer management and active surveillance programs, retooling studies to generate irrefutable and reproducible data instead of information supporting unfounded biases could restore trust in disease management.
Dedication to Anthony Horan, MD.
This article is dedicated to Anthony Horan MD, a urologist and author (The Big Scare) who fearlessly challenged the culture and the business of prostate cancer. He was always on the right side of what should never have been a controversy.
Written by Bert Vorstman MD and first published in Substack on May 11, 2022